Why it was recalled
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Product description
Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
Lot numbers, UPCs & expiration codes
Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0840-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 8, 2018
- FDA report date
- May 23, 2018
- Quantity
- 13453 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0840-2018, exactly as published.
Show all FDA fields
- City
- North York
- Status
- Terminated
- Country
- Canada
- Event ID
- 80063
- Address
- 150 Signet Dr
- Code information
- Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0840-2018
- Classification
- Class I
- Recalling firm
- Apotex Inc.
- Product quantity
- 13453 vials
- Termination date
- Oct 3, 2023
- Reason for recall
- Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- May 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 5, 2018